OrthoSera wins CE Mark for hypACT regenerative osteoarthritis device

Orthobiologics company OrthoSera GmbH said today it won CE Mark approval in the European Union for its hypACT system designed to aid in regenerating osteoarthritic bone.

The Austrian company’s hypACT device is designed to deliver its hyperacute, platelet rich plasma serum to aid in regeneration for patients with osteoarthritis and other degenerative diseases.

“After the successful launch of BoneAlbumin as our 1st commercial product in the dental field late last year this is another important milestone for our company. Following market authorization we are now making our autologous hypACT inject device available for clinical use in order to further build on the strong preclinical results of our hyperacute serum technology,” CEO Dr. Zsombor Lacza said in a press release.

The hypACT system isolates specific serum derivatives from the patient in a closed system, which can then be applied during a same-day procedure, the company said.

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